Health Ministry Considering Proposal To Issue Guidelines On Release Of SQ Drug Data

Mumbai, 8 April 2019: The Union health and family welfare ministry is actively considering a proposal to issue guidelines for releasing data of drugs declared standard quality (SQ) by Central Drugs Laboratory (CDL) and Regional Drugs Testing Laboratory (RDTL) in line with bi-monthly data of not of standard quality (NSQ) drugs released by the Central Drugs Standard Control Organisation (CDSCO).

The proposal was sent to the health ministry by Drugs Controller General of India (DCGI) following a representation by Laghu Udyog Bharati.

Laghu Udyog Bharati has been demanding release of SQ drug data of CDL and RDTL since last year. In the absence of guidelines, no SQ drug data gets published so far.

Taking serious note of their demand, DCGI has forwarded a proposal to the ministry in this regard. Now the proposal is under consideration of the ministry, DCGI informed representatives of drug associations about this at Indian Drug/Pharmaceuticals Association Forum meeting held on March 25, 2019.

The NSQ data leaves Indian drug industry in a bad shape. Though, the NSQ data is very less compared to numbers of drugs declared SQ by CDL and RDTL, it gives an opportunity to a section of people to raise hue and cry about quality of drugs manufactured by Indian drug industry. To instill confidence in people that a majority of drugs marketed in the country is safe for consumption, we have time and again demanded the release of SQ drug data, said Amit Chawla, vice-president of Laghu Udyog Bharati Indore unit. 

A majority of manufacturers adhere to good manufacturing practices to ensure quality and efficacy of drugs. India is the largest provider of generic drugs globally and accounts for 20 per cent of global exports in generics. 80 per cent of the anti-retroviral drugs used worldwide to combat AIDS are from Indian pharmaceutical companies. The quality and efficacy of drugs manufactured by domestic players has helped them to carve a niche for themselves in global generic market, said Chawla.

We hope the health ministry will soon take a call on releasing guidelines to publish SQ drug data along with NSQ drug data as it will improve image of domestic drug players as well as regulatory authorities, he added. Pharmabiz